Assessing the extent of Cutaneous Photoaging at the end of treatment. [ Time Frame: Baseline to week 24 ]

Evaluation of Cutaneous Photoaging Extension at the end of treatment: the signs of cutaneous photoaging are evaluated by means of reduction of at least one point in any one of the following parameters: periorbital wrinkles, ephelides / melanosis, forehead wrinkles, tactile roughness (texture) and actinic keratosis.

Secondary Outcome Measures:

Global Assessment of photoaging, based on the Griffiths photonumeric scale. [ Time Frame: week 24 ]

The evaluator, blinded to the treatment, will assess the global degree of photoaging of the patient in all visits, based on photographic images of the Griffiths scale consisted of 5 categories (Periorbital Wrinkles, Ephelides / melanosis, Forehead Wrinkles, Tactile roughness (texture), Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = Absent, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.

Assessing the extent of Cutaneous Photoaging at each visit. [ Time Frame: week 24 ]

The absolute values and changes of the Evaluation of Cutaneous Photoaging Extent in relation to baseline will be summarized by using frequency tables and at each visit and the groups will be compared.

Evaluation of Improvement by the Investigator at Week 12 [ Time Frame: week 12 ]

Patients will evaluate the improvement perceived at week 24 using the following scale:0 = Improves hard to notice, 1 = A very small improvement, 2 = Small improvement, 3 = Moderate improvement, 4 = Major improvements.

Anatomical-pathological assessment [ Time Frame: week 24 ]

The difference between the treatment arms in epidermal thickness and 7.7 in the thickness of the granular layer will be detect at week 24.

Digital morphometric assessment. [ Time Frame: week 24 ]

The thickness of the stratum corneum, granular layer and the epithelium will be estimated

Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.

Other Names:

Differin® Gel 0.3%

Adapalene Gel 0.3%

Active Comparator: Tretinoin

Tretinoin 0,05% emollient cream

Drug: Tretinoin

Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.

Other Name: Tretinoin emollient cream 0,05%

Eligibility

Ages Eligible for Study:

35 Years to 55 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients presenting at least some score on periorbital or frontal wrinkle or melanosis and at maximum a "Severe" score on any of the criteria considered in evaluating cutaneous photoaging extension, based on the table for assessing Cutaneous Photoaging Extent;

Male and female patients aged at least 35 years and maximum of 55 years, with skin phototype of I to IV, according to the T.B. Fitzpatrick's scale;

Individuals who have mild to moderate cutaneous photoaging, i.e., score 2-6 in the overall assessment of cutaneous photoaging, based on the Griffiths scale;

If female, individuals who cannot get pregnant (defined as post-menopausal the lack of menstrual bleeding for one year - or have undergone bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or, if in childbearing age, patients who underwent urine pregnancy test with negative results. Patients should be using an appropriate contraceptive method. In the case of oral contraceptives, the use must have been started at least one month before the study or 12 months in case of pills containing cyproterone. Patients should maintain the same contraceptive during the study and 1 additional month after completion;

For subjects under treatment for a concomitant medical condition, type and dose must be stable for at least three months prior to study entry (at least one year, in the case of hormone replacement therapy) and should not change during the study. These drugs do not include the excluded drugs cited in exclusion criterion;

Individuals able to avoid prolonged sun exposure, especially on the face during the study period and willing to use the proper techniques to avoid the sun, including the use of sunscreen provided during the study;

Individuals able to follow the study instructions and who are willing to complete all required visits;

Individuals who have signed the informed consent form before any study procedures;

Exclusion Criteria:

Patients who have participated in another clinical trial for less than 30 days;

Pregnant women, nursing mothers or women attempting to conceive;

Female patients who started hormone replacement therapy for less than one year before entering the study;

Individuals with a condition or who are in a situation that, in the opinion of the investigator, may put the objective of the study at risk, confound the results or even interfere with the individual participation. These include, but are not limited to:

Individuals with other facial skin disorders or dermatosis (scars, inflammatory acne, etc.) that can interfere with the clinical evaluation;

Patients who underwent superficial chemical peelings, microdermabrasion or exfoliation on the face in the last 3 months;

Patients who applied botulinum toxin or soft tissue fillers for facial rejuvenation in the last 6 months and do not agree on not using these products during the study;

Patients self-identified as "sensitive skin";

Patients who are not willing or able to attend the study visits;

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406080